Label: LORATADINE- loratadine oral solution
- NDC Code(s): 58602-423-11, 58602-423-24
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 31, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
-
Directions
- use only with enclosed dosing cup
adults and children 6 years and over
2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age
1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
- Other information
- Inactive ingredients
- Questions or comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)
NDC 58602-423-11
Ages
2 years
and olderLoratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Do not use if carton is opened,
or if cap safety seal is broken
or missing.- Dye-Free
- Sugar-Free
- Alcohol Free
Indoor & Outdoor Allergies
Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.
* When taken as directed. See Drug Facts Panel.
Grape Flavor
2 FL OZ (60 mL)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)
NDC 58602-423-11
#Compare to the
active ingredient in
children’s Claritin®
Ages2years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy,watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor Allergies
Dosing Cup Included
- Dye-Free
Contains sodium
metabisulfite, a sulfite
that may cause
allergic-type reactions.
* When taken as directed.
See Drug Facts Panel.
GrapeFlavor
2 FL OZ (60 mL)
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine oral solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-423 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength GRAPE (UNII: 6X543N684K) ASCORBIC ACID (UNII: PQ6CK8PD0R) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM METABISULFITE (UNII: 4VON5FNS3C) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color YELLOW (colorless to light yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-423-11 1 in 1 CARTON 06/29/2018 1 60 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:58602-423-24 1 in 1 CARTON 06/29/2018 2 120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208931 06/29/2018 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 918917642 ANALYSIS(58602-423) , MANUFACTURE(58602-423)